Do I need IRB approval for my pilot study?

Yes and no. Read this entire answer before you proceed.

Generally, a pilot study is defined as a preliminary investigation to determine the feasibility of a study. It is usually done on a small scale (usually fewer than 10 subjects) and exploratory in nature. Its purpose is to refine data collection procedures, instruments, or research design.

Pilot studies answer questions such as “in what order should the survey instruments be distributed”. These questions do not qualify as questions that will contribute to generalizable knowledge and thus pilot studies do not qualify as research and do not need IRB review and approval. Nonetheless, it is assumed that the proper steps will be taken to protect human subjects (e.g., use of informed consent, confidentiality, etc.).

NOTE: If sensitive data, vulnerable populations, or methods with more than minimal risk are to be used, a consultation with the IRB Chair or Administrator must occur before data is collected without IRB review and approval. The IRB retains the right to require review of a project characterized by the faculty member as exploratory (pilot) in nature.

If it is possible that the data collected in your pilot study will be used solely or in combination with other data for generalizable or publication purposes, IRB review and approval is required BEFORE data collection begins.   Pilot data collected for the purpose of research process refinement without inclusion in an IRB approved protocol may not be repurposed as study data. The IRB cannot provide retroactive review. Researchers are cautioned not to confuse pilot data with preliminary data. Preliminary data requires normal review processes.

Last updated: 2/21/2023